The following data is part of a premarket notification filed by Syntheon with the FDA for Syntheon Laa Exclusion System, Syntheon Laa Selection Guide.
| Device ID | K220305 |
| 510k Number | K220305 |
| Device Name: | Syntheon LAA Exclusion System, Syntheon LAA Selection Guide |
| Classification | Left Atrial Appendage Clip, Implantable |
| Applicant | Syntheon 13755 SW 119 Avenue Miami, FL 33186 |
| Contact | Sean McBryer |
| Correspondent | Elena Jugo Caraballo Consulting, LLC 11037 Bitternut Hickory Lane Boynton Beach, FL 33437 |
| Product Code | PZX |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-02 |
| Decision Date | 2022-10-28 |